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U.S. Department of Health and Human Services

Class 2 Device Recall Hitachi Altaire Magnetic Resonance Imaging Device.

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  Class 2 Device Recall Hitachi Altaire Magnetic Resonance Imaging Device. see related information
Date Initiated by Firm June 30, 2005
Date Posted June 14, 2005
Recall Status1 Terminated 3 on September 14, 2010
Recall Number Z-0888-05
Recall Event ID 32211
510(K)Number K022390  K002420  
Product Classification System, Nuclear Magnetic Resonance Imaging - Product Code LNH
Product Hitachi Altaire Magnetic Resonance Imaging Device.
Code Information L001 thru L182.
Recalling Firm/
Manufacturer		 Hitachi Medical Systems America Inc
1959 Summit Commerce Park
Twinsburg OH 44087-2371
For Additional Information Contact Doug Thistlethwaite
330-425-1313
Manufacturer Reason
for Recall		 Image reconstruction software problem that could potentially cause multiple patient images to be stored in one patient folder.
FDA Determined
Cause 2		 Other
Action The recalling firm is sending recall letters to all consignees.
Quantity in Commerce 177 devices
Distribution The product was distributed throughout the United States and to one consignee located in both Wales and London.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LNH and Original Applicant = HITACHI MEDICAL SYSTEMS AMERICA, INC.
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